Point-of-Care Focused Cardiac Ultrasound in Assessing the Thoracic Aorta
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01671618|
Recruitment Status : Completed
First Posted : August 23, 2012
Last Update Posted : June 30, 2016
|Condition or disease|
|Aortic Aneurysm, Thoracic Aortic Dissection|
Nonspecific chest pain is frequently encountered in the emergency department. Accounting for over 13,000 deaths annually, aortic aneurysmal disease is a potential cause of chest pain.There are multiple diagnostic imaging modalities in practice to interrogate the thoracic aorta, with the most common being computed tomographic angiography (CTA), trans-thoracic echocardiography (TTE) and trans-esophageal echocardiography (TEE), each with its own advantages and limitations. In the ED setting, point-of-care (POC) focused cardiac ultrasound (FOCUS) is increasingly being used as an adjunct to the emergency physician's (EP) workup of undifferentiated chest pain. Based on prior retrospective data FOCUS and CTA appear to have good agreement. This studies aims to confirm these findings through prospective evaluation
Aim 1: To prospectively compare Point of Care (POC) Focused Cardiac Ultrasound (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending aortic dimensions.
Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and statistical significance.
Hypothesis: 95% limits of agreement between FOCUS and CTA will be within +/- 5 mm.
Aim 2: To determine the diagnostic accuracy of Point-of-Care Focused Cardiac Ultrasound for the detection of thoracic aortic dilation and aneurysm with computed tomographic angiography as the reference standard
Sensitivity, Specificity and Accuracy of FOCUS will be computed with CTA as the reference standard.
|Study Type :||Observational|
|Actual Enrollment :||97 participants|
|Official Title:||A Prospective Study on Point-of-Care Focused Cardiac Ultrasound in Assessing for Thoracic Aortic Dimensions, Dilation, and Aneurysm in Correlation With CT Angiogram in Suspected Cases of Pathology|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
- Maximal diameter measurements of the proximal ascending aorta by CTA and FOCUS [ Time Frame: during emergency department visit (estimated average 3-6 hours) ]Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and statistical significance.
- Time to Emergency Department Disposition [ Time Frame: estimated time frame 3-6 hours ]Time until an admission or discharge order is placed within the electronic medical record
- Number and percent probabilities of differential diagnosis [ Time Frame: (estimated time frame 0 -3 hours) ]Number and percent probabilities of differential diagnosis will be obtained before and after ultrasound to calculate the informational content provided by the ultrasound and perform additional uncertainty analyses
- Time to diagnostic imaging [ Time Frame: estimated time frame 0-6 hours ]Time when diagnostic imaging is performed
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01671618
|United States, Connecticut|
|Yale New Haven Hospital|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Richard A Taylor, MD||Yale University|